Technical Requirements For Medical Devices

Hospital is not power off, if there is a power problem, could pose a threat to the safety of the patient. Similarly, the medical device is not powered down, so the medical equipment has very strict requirements on the specifications of the power supply. Therefore, the battery has a special specification for the design of medical equipment.

In addition, China began implementing the 12th five-year plan, of which relating to the future development of medical equipment, it has the following three objectives: 1) accelerate the development of domestic medical devices industry; 2) implementation of unified procurement system; 3) medical institutions should be given top priority in purchasing home medical equipment. With the gradual implementation of this health care reform, medical equipment manufacturers in the country are already being prepared for all riding this rare development opportunities, to develop a new generation of medical devices.

Medical devices must comply with internationally accepted standards, such as basic performance and power compliance specifications is very important, because patients ' health will be directly or indirectly affected by it. With patient care, clinical treatment, health monitoring, or scanning of electronic medical equipment, power it down if there is no power, power failure or other problem, the consequences will directly affect the patient's health, or cause temporary or permanent damage to the patient.

In laboratory apparatus or diagnostic equipment, for example, power problems would lead to medical staff not be able to make a correct diagnosis, sometimes even to do a few tests, it is a waste of time, and also increase the burden of health care personnel and patients.

In addition, medical devices in case of failure, even if not immediately pose a security problem, will also not be able to perform its basic functions, medical device developers not only in concept to plug loopholes in the design of the product, or even in the entire product life cycle management-related risks, so as to avoid equipment failure.